Methods, systems, and devices for deploying a filter from a filter device

ABSTRACT

A filter device is adapted to function as a guidewire, an exchange guidewire, and provide embolic protection during a procedure. The filter device includes a filter assembly that is either integral with or coupled to a guide member. The filter assembly includes a plurality of struts that expand outwardly to deploy a filter that collects or captures material flowing along the blood vessel within which the filter device is deployed. The plurality of struts are constrained by a restraining member or mechanism that prevents the plurality of struts from expanding or extending outwardly to deploy the filter. Cooperating with the restraining member or mechanism is an actuating assembly that is adapted to release the restraining member or mechanism and enable the filter to be deployed from the guide member. A capture catheter that cooperates with the filter device and substantially surrounds the filter during removal of the filter device.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. ProvisionalPatent Application Serial No. 60/302,417, filed Jul. 2, 2001, U.S.Provisional Patent Application Serial No. 60/345,333, filed Nov. 9,2001, U.S. Provisional Patent Application Serial No. 60/347,500, filedJan. 11, 2002 and U.S. Provisional Patent Application Serial No.60/341,092, filed Dec. 12, 2001, the disclosures of which are hereinincorporated by this reference.

[0002] Additionally, this patent application incorporates by referencethe disclosure of co-pending patent applications entitled “Methods,Systems, and Devices for providing Embolic Protection and RemovingEmbolic Material,” U.S. patent application Ser. No. ______, “Methods,Systems, and Devices for Deploying an Embolic Protection Filter,” U.S.patent application Ser. No. ______, and “Methods, Systems, and Devicesfor Providing Embolic Protection,” U.S. patent application Serial No.______.

BACKGROUND OF THE INVENTION

[0003] 1. The Field of the Invention

[0004] The present invention relates generally to the field ofpercutaneous medical filters, and more specifically, to vascular filterdevices that are configured for percutaneous insertion into a bloodvessel of a patient.

[0005] 2. The Relevant Technology

[0006] Human blood vessels often become occluded or blocked by plaque,thrombi, other deposits, or material that reduce the blood carryingcapacity of the vessel. Should the blockage occur at a critical place inthe circulatory system, serious and permanent injury, and even death,can occur. To prevent this, some form of medical intervention is usuallyperformed when significant occlusion is detected.

[0007] Several procedures are now used to open these stenosed oroccluded blood vessels in a patient caused by the deposit of plaque orother material on the walls of the blood vessels. Angioplasty, forexample, is a widely known procedure wherein an inflatable balloon isintroduced into the occluded region. The balloon is inflated, dilatingthe occlusion, and thereby increasing the intraluminal diameter.

[0008] Another procedure is atherectomy. During atherectomy, a catheteris inserted into a narrowed artery to remove the matter occluding ornarrowing the artery, i.e., fatty material. The catheter includes arotating blade or cutter disposed in the tip thereof. Also located atthe tip are an aperture and a balloon disposed on the opposite side ofthe catheter tip from the aperture. As the tip is placed in closeproximity to the fatty material, the balloon is inflated to force theaperture into contact with the fatty material. When the blade isrotated, portions of the fatty material are shaved off and retainedwithin the interior lumen of the catheter. This process is repeateduntil a sufficient amount of fatty material is removed and substantiallynormal blood flow is resumed.

[0009] In another procedure, stenosis within arteries and other bloodvessels is treated by permanently or temporarily introducing a stentinto the stenosed region to open the lumen of the vessel. The stenttypically comprises a substantially cylindrical tube or mesh sleeve madefrom such materials as stainless steel or nitinol. The design of thematerial permits the diameter of the stent to be radially expanded,while still providing sufficient rigidity such that the stent maintainsits shape once it has been enlarged to a desired size.

[0010] Unfortunately, such percutaneous interventional procedures, i.e.,angioplasty, atherectomy, and stenting, often dislodge material from thevessel walls. This dislodged material can enter the bloodstream, and maybe large enough to occlude smaller downstream vessels, potentiallyblocking blood flow to tissue. The resulting ischemia poses a seriousthreat to the health or life of a patient if the blockage occurs incritical tissue, such as the heart, lungs, kidneys, or brain, resultingin a stroke or infarction.

[0011] In general, existing devices and technology have a number ofdisadvantages including high profile, difficulty using multiple partsand components that result in an involved procedure, manufacturingcomplexity, and complex operation of the device or system.

BRIEF SUMMARY OF THE INVENTION

[0012] Embodiments of the present invention provide systems, methods,and devices for overcoming the above-referenced problems. Morespecifically, embodiments of the present invention include filterdevices that have small, low, or no profiles, few parts and components,and are simple to manufacture and use. Consequently, embodiments of thepresent invention are able to be easily inserted into a patient, besteerable through the tortuous anatomy of a patient, provide filteringcapabilities, have a sufficiently low profile to provide exchangecapability so other medical devices can be advanced along the filterdevice, and be capable of removing the captured material withoutallowing such material to escape during filter retrieval.

[0013] According to one aspect of one embodiment of present invention,an illustrative embodiment of the present invention includes a vascularfilter device. This device includes a guide member, such as a guidewireor hypo-tube having a lumen that extends from a distal end toward aproximal end thereof. Disposed within the lumen are one or moreactuating members and a filter assembly. The one or more actuatingmembers are coupled to an actuating mechanism at the proximal end of theguide member and are configured to deploy the filter assembly during aprocedure, such as through movement of one or more actuating members.

[0014] The filter assembly includes a filter and a plurality of radiallyspaced-apart struts connected to a peripheral edge of a proximal end ofthe filter. The struts expand outwardly upon being deployed from thelumen of the guide member to place the peripheral edge of the proximalend of the filter adjacent to the wall of the vessel.

[0015] The filter includes a plurality of pores or holes that are sosized to capture material that may become detached during the procedure.The proximal end of the filter is configured to be constrained againstthe blood vessel within which the filter is disposed, while the distalend, in one embodiment, is configured to “float” within the bloodflowing through the blood vessel and change shape to collect materialand maintain the flow of blood through the vessel.

[0016] In one embodiment of the present invention, the filter deviceincludes a number of radiopaque bands and/or markers affixed to avariety of positions on the device. These radiopaque bands and/ormarkers are one example of means for radiopacity, with various othermeans for radiopacity being known to those skilled in the art.

[0017] During use of the filter device of the present invention, bloodflow will cause the filter to assume a parachute-like configuration suchthat material is collected within the interior of the filter. To removethe filter and the material, in one embodiment, the actuating member ismoved in the proximal direction so that the proximal end of the filtercooperates with the distal end of the lumen through the guide member.Upon positioning the proximal end of the filter, a capture catheter ismoved or advanced along the guide member until the cathetersubstantially encloses the filter. Following positioning of the capturecatheter, the catheter and guide member are removed from the patient.

[0018] According to another embodiment of the present invention, a guidemember includes a plurality of struts disposed at the distal end of theguide member. In one configuration, the distal end of the guide memberis divided into a plurality of struts, at least two of which are biasedto move outwardly. In another configuration, a strut assembly is coupledto the distal end of the guide member, with the strut assembly includingone or more struts attached to the filter, while formed at a distal endof a third strut is a coil tip. This third strut is optionally biasedtoward the center of the lumen of the guide member. Before the filter isdeployed, the filter is folded about the distal end of the guide member,folded about one or more of the plurality of struts, and/or ispositioned within the lumen of the guide member.

[0019] To maintain the struts in the closed position, i.e., notextending outwardly from the remaining body of the guide member, aretaining member or mechanism cooperates with the guide member and/orstruts and applies a restraining force to one or more of the struts. Bymoving the guide member relative to the restraining member, or viceversa, the distal ends of two or more of the biased struts are allowedto move outwardly to deploy the filter, i.e., the restraining force isreleased.

[0020] In another configuration, the restraining member or mechanismsurrounds a tip of the guide member, including the struts and a part ofthe guide member. This restraining member or mechanism can be attachedto the struts and is configured to apply a restraining force to the oneor more struts. In one configuration, the restraining member ormechanism is configured to separate into a number of different sectionsto allow the distal ends of two or more of the biased struts to moveoutwardly to deploy the filter. In another embodiment, the restrainingmember or mechanism includes two or more actuating members that areattached to a location just proximal to the proximal end of each strut.The two or more actuating members extend to the distal end of the guidemember, pass through apertures in the distal end of the restrainingmember or mechanism, and terminate within the lumen of the guide memberafter passing through holes formed in the guide member proximal to theproximal end of each strut.

[0021] To actuate the filter device, an actuating assembly at theproximal end of the guide member draws the actuating members in theproximal direction. Since one end of the actuating member is located atthe proximal end of the restraining member or mechanism, whether formingpart of the restraining member or mechanism, attached to the restrainingmember or mechanism, or attached to the guide member, pulling theactuating member in the proximal direction causes the actuating memberto preferentially separate the restraining member or mechanism, therebyreleasing the strut.

[0022] In another configuration, the restraining member or mechanismincludes a plurality of apertures formed therein. The restraining memberor mechanism has a first portion and a second portion with one or moreof the plurality of apertures formed therein. The restraining member ormechanism further includes a securing member that passes through one ormore of the plurality apertures to cause the first portion to bereleasably connected to the second portion. The securing member passesthrough an aperture in the guide member and/or a strut assembly to passinto the end of the guide member and extend toward the proximal end.Upon moving the securing member in a proximal direction using one of avariety of different actuating mechanisms, a distal end of the securingmember is removed from the apertures and the first and second bothportions of the restraining member or mechanism. In this manner, theforce applied to the struts to maintain a closed configuration, wherethe struts are retained or prevented from extending outwardly, isreleased from the struts, enabling them to deploy the filter.

[0023] In still another configuration, the restraining member ormechanism includes a securing member that is “sewn” through portions ofthe restraining member. In a similar manner to the configurationdiscussed above, the securing member can be removed from cooperatingwith the restraining member or mechanism to allow the struts to extendoutwardly and deploy the filter.

[0024] In still another configuration, the restraining member ormechanism includes a plurality of channels. These channels are formed onboth first and second ends of the filter in an offset configuration. Thesecuring member can pass through one or more of the channels formed inthe first side and the second side to maintain the first side incooperative engagement with the second side. In this manner, therestraining member or mechanism applies a restraining force to the oneor more struts and prevents them from extending outwardly. Upon movingthe securing member in a proximal direction, a distal end of thesecuring member is removed from within the channels formed in the firstside and second side, thereby releasing the restraining force applied bythe restraining member or mechanism against the one or more struts.

[0025] In still another configuration, the restraining member ormechanism has the form of a sleeve that is adapted with one or morehoops formed therein. The wire forms a channel by maintaining a firstset of hoops and second set of hoops in engagement using a securingmember. By removing the securing member from engaging within one or moreof the hoops, the first side and second side of the restraining memberor mechanism can disengage with one another and release the restrainingforce that was applied to the one or more struts. In this manner, thestruts are able to deploy the filter.

[0026] In yet another configuration, the restraining member or mechanismis combined with the one or more struts of the filter device. In such aconfiguration, two or more of the struts include tubular members adaptedto receive a securing member. As the struts are brought towards eachother, the lumens of the tubular members become aligned so that thesecuring member can pass therethrough to prevent the struts fromextending outwardly or otherwise maintain the struts together or inclose proximity one to another.

[0027] In still another configuration, the restraining member ormechanism is combined with the filter of the filter device. In thisconfiguration, the filter includes at least one flap that is adapted toextend through the gap disposed between two struts. The flap(s) can bewrapped around the struts and secured to prevent the struts fromextending outwardly.

[0028] These and other objects and features of the present inventionwill become more fully apparent from the following description andappended claims, or may be learned by the practice of the invention asset forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] To further clarify the above and other advantages and features ofthe present invention, a more particular description of the inventionwill be rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope. The invention willbe described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

[0030]FIG. 1 illustrates an exemplary filter device according to oneembodiment of the present invention.

[0031]FIG. 2 illustrates an exploded perspective view of an exemplarytip of the filter device of FIG. 1.

[0032]FIG. 3 illustrates a cross-sectional side view of the exemplarytip of the filter device of FIG. 2.

[0033] FIGS. 4A-4I illustrates various cross-sectional side views ofdifferent exemplary configurations or embodiments of the tip of thefilter device of FIG. 2.

[0034]FIG. 5 illustrates a cross-sectional side view of the tip of thefilter device of FIG. 2 with exemplary actuating member and filterassembly in a closed position.

[0035]FIG. 6a illustrates a cross-sectional side view of the tip of thefilter device of

[0036]FIG. 2 with exemplary actuating member and filter assembly in anactuated position.

[0037]FIG. 6b illustrates one or more pores of the filter of the filterdevice of the present invention.

[0038]FIG. 7 illustrates a cross-sectional side view of the tip of thefilter device of FIG. 2 with exemplary actuating member and filterassembly in an actuated position and a portion of the filter filled withmaterial.

[0039]FIG. 8 illustrates a cross-sectional side view of the tip of thefilter device of FIG. 2 with exemplary actuating member and filterassembly in a retracted position.

[0040]FIG. 9 illustrates a cross-sectional side view of an exemplaryactuating assembly of the filter device of FIG. 2.

[0041]FIG. 10 illustrates a perspective view of one exemplary capturecatheter adapted for use with the filter device of the presentinvention.

[0042]FIG. 11 illustrates a cross-sectional side view of the actuatingmember and filter assembly in a retracted position with the capturecatheter in position surrounding the filter of the filter device of FIG.2.

[0043]FIG. 12 illustrates a flow diagram of an exemplary method forusing the filter device of FIG. 2.

[0044]FIG. 13 illustrates a portion of the vasculature of an individualwithin which the filter device of FIG. 2 can be inserted.

[0045]FIG. 14 illustrates a lesion formed in the interior carotid arteryof the individual of FIG. 13.

[0046]FIG. 15 illustrates one embodiment of the filter device of FIG. 2deployed in the interior carotid artery distal of the lesion of FIG. 14.

[0047]FIG. 16 illustrates one embodiment of the filter device of FIG. 2deployed in the interior carotid artery distal of the lesion of FIG. 14and a pre-dilation balloon.

[0048]FIG. 17 illustrates one embodiment of the filter device of FIG. 2deployed in the interior carotid artery distal of the lesion of FIG. 14and a stent located about the lesion.

[0049]FIG. 18 illustrates a partial cross-sectional side view of anotherembodiment of the filter device of the present invention.

[0050]FIG. 19 illustrates a cross-sectional side view of anotherexemplary actuating assembly of the filter device according to thepresent invention.

[0051]FIG. 20 illustrates a partial cross-sectional view of yet anotherembodiment of the filter device of the present invention.

[0052]FIG. 21 illustrates a side view of a tip of the filter device ofFIG. 20.

[0053]FIG. 22 illustrates a side view of the embodiment of FIG. 20 withthe filter deployed.

[0054]FIG. 23 illustrates a side view of yet another embodiment of afilter device with a restraining member coupled to the filter deviceaccording to another aspect of the present invention.

[0055]FIG. 24 illustrates a side view of the embodiment of FIG. 23 withthe filter deployed.

[0056]FIG. 25 illustrates a cross-sectional side view of anotherexemplary actuating assembly of the filter device according to thepresent invention.

[0057]FIG. 26 illustrates a perspective view of another embodiment of afilter device with a restraining member coupled to the filter deviceaccording to another aspect of the present invention.

[0058]FIG. 27 illustrates a perspective view of the restraining memberof FIG. 26 before becoming coupled to the filter device according toanother aspect of the present invention.

[0059]FIG. 28 illustrates a perspective view of the restraining memberof FIG. 26 before becoming coupled to the filter device according toanother aspect of the present invention.

[0060]FIG. 29 illustrates a perspective view of another restrainingmember of the filter device according to another aspect of the presentinvention.

[0061]FIG. 30 illustrates a perspective view of another embodiment of afilter device with a restraining member coupled to the filter deviceaccording to another aspect of the present invention.

[0062]FIG. 31 illustrates a perspective view of the restraining memberof FIG. 30 before becoming coupled to the filter device according toanother aspect of the present invention.

[0063]FIG. 32 illustrates a side view of the restraining member of FIG.30 before becoming coupled to the filter device according to anotheraspect of the present invention.

[0064]FIG. 33 illustrates a side view of the restraining member FIG. 30part way through restraining the filter device according to anotheraspect of the present invention.

[0065]FIG. 34 illustrates a side view of the restraining member FIG. 30as it restrains the filter device according to another aspect of thepresent invention.

[0066]FIG. 35 illustrates a perspective view of another embodiment of afilter device with a restraining member coupled to the filter deviceaccording to another aspect of the present invention.

[0067]FIG. 36 illustrates a perspective view of another embodiment of afilter device with a restraining member coupled to the filter deviceaccording to another aspect of the present invention.

[0068]FIG. 37 illustrates a side view of the restraining member of FIG.36 before becoming coupled to the filter device according to anotheraspect of the present invention.

[0069]FIG. 38 illustrates a side view of the restraining member of FIG.36 before becoming coupled to the filter device according to anotheraspect of the present invention.

[0070]FIG. 39 illustrates perspective view of the restraining memberFIG. 36 as it restrains the filter device according to another aspect ofthe present invention.

[0071]FIG. 40 illustrates a perspective side view of another embodimentof a filter device with a restraining member coupled to the filterdevice according to another aspect of the present invention.

[0072]FIG. 41 illustrates a perspective side view of the restrainingmember FIG. 40 as it restrains the filter device according to anotheraspect of the present invention.

[0073]FIG. 42 illustrates a side view of another embodiment of a filterdevice according to another aspect of the present invention.

[0074]FIG. 43 illustrates a side view of yet another embodiment of afilter device according to another aspect of the present invention.

[0075]FIG. 44 illustrates a perspective view of another embodiment of acapture catheter used with the filter device of the present invention.

[0076]FIG. 45 illustrates a perspective view of yet another embodimentof a capture catheter used with the filter device of the presentinvention.

[0077]FIG. 46 illustrates a perspective view of still another embodimentof a capture catheter used with the filter device of the presentinvention.

[0078]FIG. 47 illustrates a side view of the capture catheter of FIG. 46as it begins to capture the filter device of the present invention.

[0079]FIG. 48 illustrates a side view of the capture catheter of FIG. 46as it captures the filter device of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0080] The present invention generally relates to percutaneous filterdevices, systems, and methods of using the same. Embodiments of thepresent invention can be utilized in association with devices, systems,and methods for inserting a filter device, such as but not limited to avascular filter device, within any blood vessel of a patient.

[0081] One or more of the embodiments of the filter devices of thepresent invention meet criteria for both guidewires and filter devices.For instance, it is preferable that a guidewire is steerable.Consequently, embodiments of the filter device of the present inventioncan be insertable within any blood vessel of a patient, such as but notlimited to, coronary artery, carotid arteries, renal arteries, bypassgrafts, superficial femoral artery, the arteries of the upper and lowerextremities, or cerebral vasculature, and manipulated and steered by aphysician to traverse the tortuous anatomy of the patient to a lesion orocclusion.

[0082] To assist the physician with the above-recited endeavor, one ormore embodiments of the filter device include a shapeable, soft, distaltip. In addition, the filter device is capable of translating rotationalmovement or force applied to the proximal end thereof substantiallyequally to the distal end. In other words, with the filter devicepositioned within a vessel of the patient, as a physician rotates theproximal end of the filter device, the distal end of the filter devicerotates substantially having a one-to-one torqueability.

[0083] Further, the filter device of the present invention is kinkresistant and is capable of receiving a variety of different coatings toimprove lubricity, have anti-thrombogenic properties, and/or reduceplatelet aggregation. These coatings can include, but are not limitedto, a hydrophilic coating, a heparinized coating, Teflon, silicone, orother coating known to those skilled in the art in light of the teachingcontained herein.

[0084] With respect to the filter of the filter device of the presentinvention, in one embodiment, the filter is configured to capturematerial of a variety of sizes and enable removal of the capturedmaterial. Therefore, filter pore sizes and shapes can be selected basedupon the size of material to be captured. The material can include butis not limited to, particulates, thrombi, any atherosclerosis or plaquematerial dislodged during a procedure, or other foreign material thatmay be introduced in to the vasculature of the patient.

[0085] Referring now to FIG. 1, depicted is one embodiment of a vascularfilter device, designated by reference number 10, of the presentinvention. As illustrated, filter device 10 includes a guide member 12having a distal end 14 and a proximal end 16. Extending between distalend 14 and proximal end 16 of guide member 12 is a lumen 18 within whichis disposed an actuating member 40 and a filter assembly 42. Distal end14 of guide member 12 includes a tip 15 that is configured forpercutaneous insertion into a blood vessel of a patient, while proximalend 16 is configured with or couples to an actuating assembly 20.

[0086] In this configuration, filter device 10 is capable of beinginsertable into any blood vessel of a patient or body and function as aguidewire or exchange wire for other medical components or devices, suchas but not limited to catheters, stents, balloons, atherectomy devices,or other components or devices that can be exchanged using a guidewire.Further, filter device 10 can be used to filter particulates, as will bedescribed in more detail hereinafter, thereby acting or providingembolic protection during a procedure.

[0087] Illustratively, the term “guide member” can refer to a memberthat is completely solid, such as a guidewire, a member that partiallyincludes a lumen therein, or a member that includes a lumen extendingfrom a proximal end to a distal end thereof, such as a hypo-tube.Consequently, the term “guide member” can include or encompass aguidewire or a hypo-tube that is configured to perform the functionsdescribed herein.

[0088] Guide member 12 can be fabricated from a variety of materials.For example, guide member 12 can be fabricated from Nitinol, steel,metals, metal alloys, composites, plastic, polymer, synthetic materials,or combinations thereof. Further, guide member 12 can be covered with avariety of different coatings, such as but not limited to, coatings toimprove lubricity or having anti-thrombogenic properties, reduceplatelet aggregation, hydrophilic coatings, a heparinized coating,Teflon, silicone, or combinations thereof.

[0089] Illustratively, guide member 12 can have an outside diameter ofbetween about 0.010 inches to about 0.035 inches, between about 0.014inches to about 0.018 inches, or between about 0.010 inches to about0.018 inches. In one configuration, the outside diameter of guide member12 is about 0.014 inches. Similarly, the diameter of lumen 18 can rangefrom about 0.004 inches to about 0.029 inches or between about 0.008inches to about 0.014 inches. In one configuration, the diameter oflumen 18 is about 0.008 inches.

[0090] As illustrated in FIGS. 2 and 3, the exemplary distal end 14 ofguide member 12 has a step configuration, with a step portion 22 ofguide member 12 having a smaller diameter than other portions of guidemember 12. For ease of explanation, actuating member 40 and filterassembly 42 have been excluded from FIGS. 2 and 3.

[0091] The step portion 22 can have a variety of differentconfigurations so long as it is adapted to couple with other portions offilter device 10. For instance, step portion 22 can include multiplesteps instead of a single step as illustrated in FIG. 2. Consequently,distal end 14 of guide member 12 could include a first step portionhaving a first outer diameter smaller than the outer diameter of theremaining portion of guide member 12 toward proximal end 16 thereof.Further, distal end 14 of guide member 12 could include a second stepportion having a smaller outer diameter than the first outer diameter ofthe first portion.

[0092] Attached to step portion 22 of guide member 12 is a sheath 24.Sheath 24 has a lumen 30 that extends between a distal end 26 and aproximal end 28 thereof. A portion of distal end 26 is substantiallyco-planar with distal end 14 of guide member 12 when sheath 24 isconnected to guide member 12. Stated another way, a portion of distalend 14 of guide member 12 and distal end 26 of sheath 24 are containedwithin a plane that is substantially perpendicular to the longitudinalaxis of lumen 18 of guide member 12 when sheath 24 is coupled,connected, or attached to guide member 12. Although this is the case inone embodiment of the present invention, one skilled in the art canidentify various other configurations where this need not be the case.For instance, in an alternate configuration, distal ends 14 and 26 arenot co-planar. In another configuration, portions of distal ends 14 and26 are co-planar. In still another configuration, at least one of distalends 14 and 26 is angularly orientated relative to the longitudinal axisof lumen 18 or lumen 30.

[0093] As illustrated in FIG. 3, distal end 26 of sheath 24, eitheralone or in combination with distal end 14 of guide member 12 isatraumatic. In this manner, as filter device 10 is inserted within ablood vessel filter device 10 is able to slide along the interiorsurface of the blood vessel and is prevented from catching uponprotrusions, i.e., lesions, occlusions, stenosis, or the like, during aprocedure. One skilled in the art can identify a variety of differentconfigurations of distal ends 14 and/or 26 to perform such a desiredfunction. For instance, the curvature of distal end 14 of guide member12 can be varied as long as the curvature allows filter device 10 toslide along the interior surface of the blood vessel without catchingupon protrusions; the curvature can be based upon distal end 14 of guidemember 12 and/or the distal end of sheath 24.

[0094] Proximal end 28 of sheath 24 is configured to cooperate with aproximal end of step portion 22. Proximal end 28 of sheath 24 and theproximal end of step portion 22 are substantially parallel one toanother upon coupling, connecting, or attaching sheath 24 to stepportion 22. In another configuration, the proximal end of step portion22 can include one or more raised portions within which one or morecomplementary recesses formed in proximal end 28 mate, or vice versa. Instill another configuration, sheath 24 has a stepped configuration thatallows matting with a complementary configured stepped proximal end ofstep portion 22, such as when step portion includes multiple steps.Various other configurations are applicable to allow sheath 24 and theremainder of guide member 12 to couple, connect, or be attached one toanother.

[0095] According to another aspect of one embodiment of the presentinvention, sheath 24 has an outside diameter substantially the same asthe outer diameter of guide member 12, while the diameter of lumen 30 issubstantially the same as the outer diameter of step portion 22.Consequently, when sheath 24 is coupled to guide member 12 at stepportion 22, guide member 12 has substantially the same outer diameteralong its length. In other configurations, sheath 24 has a smaller orlarger diameter than guide member 12.

[0096] As illustrated, sheath 24 is configured to friction fit to stepportion 22. Consequently, the inner diameter of sheath 24 is configuredto securely mount to step portion 22 upon slidable engagement of sheath24 and step portion 22. In other configurations, sheath 24 can beaffixed to step portion 22 with an adhesive, such as but not limited to,any medical grade adhesive, UV curable adhesive, or other adhesive thatcause sheath 24 to securely connect to step portion 22. In still anotherconfiguration, sheath 24 can be press fit, soldered, mechanicalattached, or coupled to guide member 12 using any other mechanism thatcauses sheath 24 to be securely connected to step portion 22. In stillother configurations, sheath 24 and step portion 22 have a keyconfiguration where sheath 24 includes at least one key and step portion22 includes at least one key way to receive the at least one key, orvice versa.

[0097] In general, sheath 24 can be fabricated from a variety ofdifferent materials and have a variety of different configurations. Forexample, sheath 24 can be fabricated from steel, titanium, platinum,metals, metal alloys, composites, plastics, polymers, syntheticmaterials, or combinations thereof. Further, sheath 24 can include meansfor radiopacity. Additionally, sheath 24 can be fabricated from (i) aradiopaque substance, (ii) a non-radiopaque substance and coated with aradiopaque substance, or (iii) a non-radiopaque substance doped with aradiopaque substance. The radiopaque substances can include, but notlimited to, barium sulphate, bismuth subcarbonate, titanium dioxide,combinations thereof, or other radiopaque substances. In still anotherconfiguration, sheath 24 can include one or more markers that haveradiopaque characteristics. These markers can be fabricated from aradiopaque material, whether the material is radiopaque, anon-radiopaque material coated with a radiopaque material, or anon-radiopaque materials doped with a radiopaque material. Consequently,sheath 24 can include means for radiopacity, whether such means resultsfrom the materials forming sheath 24 or from attaching, coupling, orconnecting markers, bands, or other indicators having radiopaqueproperties or characteristics.

[0098] Disposed over sheath 24 and optionally a portion of guide member12 is cover 32. Cover 32 is configured to seal and secure sheath 24 toguide member 12. Consequently, cover 32 acts as a means for securingsheath 24 to guide member 12. In one embodiment, cover 32 is a thinwalled plastic heat shrink tubing or silicon tubing. In otherconfigurations, interference fit or compression fit plastics, polymers,synthetic materials, or silicon can be used that need not be heatshrunk. In general, cover 32 can be a medical grade synthetic material.

[0099] According to another aspect of the present invention, distal end14 of guide member 12, distal end 26 of sheath 24, and/or the distal endof cover 32 can be configured, collectively, to form a bullet nose orhave a curved profile. This can be in addition to or alternatively fromonly distal end 14 of guide member 12 and/or distal end 26 of sheath 24being curved or being atraumatic.

[0100] Collectively, distal end 14 of guide member 12, sheath 24, andcover 32 form tip 15 of filter device 10. Although this is oneconfiguration, one skilled in the art can appreciate that tip 15 can beformed solely from or any combination of guide member 12, sheath 24, andcover 32.

[0101] To provide flexibility to tip 15 of filter device 10, embodimentsof the present invention may include one or more grooves 34 that extendentirely or partially through one or more of distal end 14 of guidemember 12, sheath 24, and cover 32, as illustrated in FIGS. 4A-4I. Theflexibility of tip 15 allows a physician or clinician to shape the tipand enable the guide member to be steered during a procedure.Consequently, the tip may maintain a level of resiliency so that acurvature defined by the physician or clinician is maintained duringmovement of the guide member through the tortuous anatomy of a patient.

[0102] The term “groove” includes one or more cuts or slits thatpartially or completely extend through a portion of filter device 10,optionally including the sleeve and the securing member. Further, theterm “groove” includes one or more cuts or slits that partially orcompletely surrounds a portion of filter device 10, whether or not suchone or more cuts or slits extend completely or partially through one ormore of the guide member, the sleeve, or the securing member.

[0103] Each groove 34 can have a variety of different configurations,such as but not limited to straight, helical, geometric, or combinationsthereof. For instance, a single groove 34 can extend around all or aportion of tip 15 and optionally extend into the remainder of filterdevice 10. Further, any number of grooves 34 can be included in tip 15of filter device 10 depending upon the degree of flexibility needed fora procedure. For example, the more grooves 34 included in tip 15 offilter device 10, the greater the flexibility. Similarly, the depth ofeach groove 34 can vary depending upon the flexibility desired. Forinstance, the deeper grooves 34 the greater the flexibility of tip 15 offilter device 10. Similarly, difference in the configuration of eachgroove 34 can affect the flexibility of tip 15 of filter device 10. Forinstance, the steeper the sides of grooves 34, the less flexibility oftip 15.

[0104] As illustrated in FIGS. 4A-4I, grooves 34 can be disposed alongthe longitudinal length of tip 15 of filter device 10 equally,gradually, continuously, periodically, or combinations thereof. Forinstance, as shown in FIG. 4A, tip 15 includes a single helical groove34 that has an equal pitch along the length of tip 15, while FIG. 4Bdepicts a single helical groove 34 that has a gradually increasing pitchalong the length of tip 15. Although not shown, it can be understoodthat tip 15 can include a single helical groove 34 that has a graduallydecreasing pitch along the length of tip 15 from the proximal end to thedistal end thereof.

[0105] As shown in FIG. 4C, tip 15 can have a plurality of individualgrooves 34 disposed along the length of tip 15. It can be understoodthat each groove 34 need not encircle tip 15 of guide member 12; rather,each groove 34 can partially encircle tip 15 of guide member 12, asdepicted illustratively in FIG. 4D.

[0106]FIG. 4E depicts a configuration of tip 15 where groupings ofgrooves 34, whether straight, helical, or geometric, are disposed atdifferent portions of tip 15.

[0107]FIG. 4F depicts a configuration where grooves 34 are large andhave shallow sides, i.e., the angle between the axis of the groove thatpasses through the apex of the groove and the side of the groove islarge. In the alternative, each groove 34 can be small and have steepsides, i.e., the angle between the axis of the groove that passesthrough the apex of the groove and the side of the groove is small.

[0108]FIG. 4G illustrates a configuration of tip 15 of filter device 10where the pitch between adjacent grooves is increasing from the proximalend to the distal end of tip 15 and the depth of each groove 34 varies,i.e., each groove 34 need not extend the entire depth of tip 15 offilter device 10.

[0109]FIG. 4H illustrates a configuration of tip 15 of filter device 10wherein grooves 34 are straight and extend into lumen 18, while FIG. 41illustrates a configuration where grooves 34 are helical and extend fromthe exterior of tip 15 to lumen 18.

[0110] The above described configurations of the grooves with tip 15 offilter device 10 are only illustrative and should not be considered aslimiting the applicability of other configurations as known by oneskilled in the art in light of the teaching contained herein. Forinstance, grooves 34 can pass through securing member 32, sleeve 24, andterminate in guide member 12, can pass through sleeve 24 and terminatein guide member 12, be contained solely in guide member 12, combinationsthereof, or the like.

[0111] Generally, grooves 34 can be formed in tip 15 of filter device 10using a variety of different techniques, such as but not limited to,micro-machining, grinding, etching, laser cutting, abrasive water jet,electrical discharge machine, or the like. Further, grooves 34 can havea pitch of between about 0.015 inches to about 0.100 inches, from about0.020 inches to about 0.060 inches, or from about 0.025 inches to about0.050 inches.

[0112] Referring now to FIG. 5, depicted is a partial cross-sectionalview of a lumen 18 of guide member 12. Disposed within lumen 18 of guidemember 12 are an actuating member 40 and a filter assembly 42. Actuatingmember 40 forms part of actuating assembly 20 and is adapted to deployand partially or completely retract filter assembly 42. Additionally,actuating member 40 provides structural support to filter device 10 andassists with preventing kinking of filter device 10.

[0113] The actuating member 40 extends toward a proximal end 16 offilter device 10. As illustrated, the distal end of actuating member 40includes a head 44. Head 44 has a generally cylindrical form and isconfigured to create a seal between actuating member 40 and the interiorwalls of lumen 18. In other embodiments of the present invention, theremainder of actuating member 40 is configured to create a seal betweenactuating member 40 and the interior walls of lumen 18. Alternatively,actuating member 40 and head 44 are not configured to create a seal withthe interior walls of lumen 18, rather a separate seal, such as but notlimited to, one or more O-rings, quad-rings, V-rings, gaskets,combinations thereof or other structure capable of creating a seals ismounted to head 44 to create a seal between the interior wall of lumen18 and head 44.

[0114] The head 44 of actuating member 40 cooperates or engages withfilter assembly 42 and forces filter assembly 42 from the distal end oflumen 18 as actuating member 40 is moved during a procedure. By sodoing, a filter 50 of filter assembly 42 is deployed to collectmaterial. Further, head 44 can be moved within lumen 18 by actuatingmember 40 to retrieve filter assembly 42, thereby aiding with removal ofthe collected material subsequent to a procedure or to allow forrepositioning of filter 50 of filter assembly 42. The head 44 andactuating member 40 can have various other configurations so long asactuating member 40 is capable of deploying and retrieving filterassembly 42. For instance, in another configuration, actuating member 40can be devoid of head 44 and be formed from a plurality of wires,strands, or members that are braided together, connected to, or formedas part of filter assembly 42.

[0115] Actuating member 40 and head 44 can be fabricated from a varietyof different materials, such as but not limited to, stainless steel,tungsten, titanium, platinum, Nitinol, other metals, alloys thereof,composites, plastics, polymers, synthetic materials, D or combinationsthereof.

[0116] Referring now to FIG. 6a and 6 b, depicted is filter assembly 42in a deployed position following movement of actuating member 40 in thedistal direction. As illustrated, filter assembly 42 includes filter 50and a plurality of radially spaced-apart struts 52 extending from filter50 to head 44 of actuating member 40. Filter 50 has a distal end 54separated from a proximal end 58 by an intermediate portion 56. Aperipheral edge of proximal end 58 is secured to struts 52 to form anopening 60 that allows material to flow into filter 50, while distal end54 is closed to prevent material from escaping or exiting from filter50.

[0117] Although in one configuration filter is hemispherical, it can beunderstood that filter 50 can be a variety of configurations, such asbut not limited to, hemispherical, conical, cylindrical, combinationsthereof, or any other configuration that allows for material to becollected therein, while the opening of the filter substantially extendsto the peripheral surface of the blood vessel within which the filter isdisposed. More generally, filter 50 can have any configuration so longas proximal end 58 has an opening that allows material to flow intofilter 50 and distal end 54 is closed to prevent material from escapingor exiting from filter 50.

[0118] Intermediate portion 56 and distal end 54 are free to float inthe blood flow or stream within the blood vessel, while proximal end 58is in a fixed relationship with actuating member 40 through struts 52.By allowing intermediate portion 56 and distal end 54 of filter 50 tofloat, as filter collects material, such as illustrated in FIG. 7, thematerial creates drag on filter 50 so that the shape of filter 50changes, while maintaining substantially the same volume as whendeployed. Consequently, blood can continue to flow through portions ofintermediate portion 56 as distal end 54 continues to fill withmaterial, as indicated by arrows A and B in FIG. 7. In this manner,material can be collected as blood flow is maintained through filter 50.

[0119] Filter 50 can be fabricated from a variety of differentmaterials, such as but not limited to, a woven or braided plastic ormetallic mesh, a perforated polymer film, a Nitinol mesh, combinationsthereof, or other material that is capable of capturing material withinflowing blood, while allowing the blood to flow through the pores orapertures thereof. Generally, filter 50 can be fabricated from a varietyof materials so long as filter 50 is capable of being packed withinlumen 18, floating in the blood flow or stream passing through the bloodvessel within which it is inserted, and is bio-compatible.

[0120] Filter 50 can have a variety of differently sized pores 51ranging from about 50 microns to about 200 microns, from about 60microns to about 180 microns, or from about 75 microns to about 150microns. For instance, as illustrated in FIG. 6b, pores 51 can have avariety of different configurations, such as but not limited tocircular, oval, polygonal, combinations thereof or other configurationsknown to one skilled in the art in light of the teaching containedherein. In one configuration, therefore, filter 50 can includes poresthat are differently sized and configured. Consequently, a major orminor axis of each pore can have a variety of different sizes rangingfrom about 50 microns to about 200 microns, from about 60 microns toabout 180 microns, or from about 75 microns to about 150 microns.Generally, the pore size can vary as needed, so long as the pores aresized so that the pores do not compromise blood flow through the filter,i.e., prevent blood flowing through the filter, and collect materialthat could potentially occlude smaller downstream vessels, potentiallyblocking blood flow to tissue or result in stroke or infarction.

[0121] In addition to the above, filter 50 can be coated with ahydrophilic coating, a heparinized coating, Teflon, silicone,combinations thereof, or various other coatings as know or desired byone skilled in the art in light of the teaching contained herein.

[0122] Referring again to FIG. 6a, connecting filter 50 to head 44, andoptionally directly to actuating member 40, are struts 52. Asillustrated, the distal ends of struts 52 are connected at radiallyspaced-apart locations about the peripheral edge of proximal end 58 offilter 50. The struts 52 attach to filter 50 on the exterior of filter50, on the interior of filter 50, along the edge of filter 50, throughfilter 50, or combinations of one or more of the above. The struts 52can be attached to filter 50 and/or actuating member 40 by medical gradeadhesives, such as but not limited to, ultra violet curable adhesives,acrylics, cyanoacrylates, solvent bonding, radio frequency or ultrasonicbonding, or some other manner to securely connect the distal end of oneor more struts 52 to filter 50. Alternatively, struts 52 can bethermally bonded to filter 50 and/or actuating member 40, such as whenstruts 52 are fabricated from a material allowing such thermal bonding.In another configuration, struts 52 are woven into filter 50 or aredistally formed with hooks or loops that are can be used to attachstruts 52 to filter 50. In still another configuration, struts 52 can belengthened strands of filter 50 that extend from filter 50 to actuatingmember 40. In still another configuration, struts 52 are extensions orstrands of actuating member 40, such as when actuating member 40 is abraided wire, a slit tube, or other member that is capable of performingthe functions described herein with respect to actuating member 40. Instill another configuration, struts 52 are extensions of filter 50 thatextend to head 44 and connect thereto.

[0123] As illustrated, each strut 52 is formed from Nitinol, stainlesssteel, metals, alloys, composites, plastics, polymers, syntheticmaterials, combinations thereof, or other materials that allow struts toperform one or more of the functions described herein. Each strut 52 canhave a generally curved distal portion 62 and may be biased to extendradially outward when filter 52 is to be deployed. In this manner,distal portion 62 is in close proximity to the wall of the blood vesselwithin which filter device 10 is inserted when deployed. The struts 52extend the edge of proximal end 58 of filter 50 into contact with thewall of the blood vessel. By so doing, the proximal end 58 of filter 50can contact a substantial portion of the wall of the blood vessel andaccommodate for variations in the profile of the wall.

[0124] Although, reference is made to the edge of proximal end 58contacting the blood vessel, other configurations of the presentinvention locate the edge of proximal end 58 adjacent to, in closeproximity to, juxtaposed, or contiguous with the wall of the bloodvessel. This can be the case, so long as material can be capturedthrough opening 60 and material is not captured between the outersurface of filter 50 and the wall of the blood vessel within whichfilter device 10 is inserted.

[0125] Referring now to FIG. 8, depicted is filter 50 in the captured orretrieved position. When actuating member 40 is moved in the proximaldirection, opening 60 of filter 50 is drawn toward distal end 14 ofguide member 12. As actuating member 40 is moved in the proximaldirection, the interior wall of lumen 18 forces struts 52 inwardly.Simultaneously, distal end 62 of each strut 52 moves inwardly to closeopening 60. This simultaneous motion prevents material trapped withinthe interior of filter 50 from escaping. Opening 60 can alternatively besubstantially completely closed following the initial movement ofactuator member 40 in the proximal direction. In still anotherconfiguration, opening 60 can be partially closed as actuator member 40is moved in the proximal direction and gradually becomes substantiallycompletely closed upon a substantial portion of struts 52 beingretracted into lumen 18 of filter device 10. In still anotherconfiguration, opening 60 can be substantially completely closed upon aportion of struts 52 being retracted into lumen 18 of filter device 10.

[0126] To move actuating member 40 in the proximal direction and/ordistal direction filter device 10 includes an actuating assembly 20. Theactuating assembly 20 can be integrated with guide member 12 and/orseparate therefrom. With reference to FIG. 9, depicted in anillustrative configuration of actuating assembly 20.

[0127] Referring now to FIG. 9, depicted is an exemplary embodiment ofan actuating assembly 20 that can be used to manipulate actuating member40. Through operating actuating assembly 20, filter assembly 42 (FIG. 5)can be deployed and retrieved.

[0128] As illustrated, actuating assembly 20 includes an actuatingelement 70 and actuator member 40. Actuating element 70 includes adistal end 74 that is configured to cooperate with guide member 12,while a proximal end 76 of actuating element 70 is attached to proximalend 16 of guide member 12. The distal end 74 has a step configurationand includes indentations 78 that are configured to cooperate withcomplementary protrusions 80 formed in guide member 12. As actuatingelement 70 is moved in the distal direction, indentations 78 andprotrusions 80 mate to position actuating element 70 in a desiredlocation relative to proximal end 16 of guide member 12, therebypositioning filter assembly 42 in a selected position, such as in theretracted position illustrated in FIG. 9.

[0129] As actuating element 70 is continually moved in the distaldirection, distal end 74 meets a wall 82 formed in guide member 12 thatprevents further movement in the distal direction. Through thisconfiguration, actuating element 70 is prevented from excessivelongitudinal displacement in the distal direction. This stopping of thelongitudinal displacement of actuating element 70 indicates that filterassembly 42 is deployed.

[0130] Although reference is made to one manner to indicate theparticular location filter assembly 42, one skilled in the art canidentify a variety of different manners. For instance, a plurality ofindentations and/or protrusions can be included within actuating element70 and guide member 12 to control the distance which actuating element70 and consequently filter assembly 42 is moved. In anotherconfiguration, a wall formed in actuating element 70 mates with thedistal end of guide member 12 to prevent excessive longitudinaldisplacement in the distal direction. In still another configuration, acombination of walls in actuating element 70 and guide member 12 can beused. In still another configuration, distal end 76 of actuating element70 is tapered and cooperates with a taper formed in proximal end 16 ofguide member 12. The complementary tapers control the longitudinaldisplacement of actuating element 70 relative to proximal end 16 ofguide member 12. In still other configurations, a combination ofindentations, protrusions, walls, or tapers can be used. Various othermanners are known to control the distance traveled by actuator element70 while indicating the position of filter assembly 42.

[0131] To remove filter device 10 from within the patient, embodimentsof the present invention provide a capture catheter 90, as shown in FIG.10. Capture catheter 90 is adapted to enclose filter 50 to preventfilter from tearing or catching on stents, grafts, other implants, guidemembers, catheters, sheaths, or other protrusions that may beencountered as filter 50 is removed from the patient.

[0132] As illustrated in FIG. 10, capture catheter 90 has a generallyelongate form having a lumen 92 extending from a distal end 94 to aproximal end 96 thereof. Disposed at distal end 94 is at least oneradiopaque marker or band 100 that aids a physician or clinician inplacing capture catheter 90 in the desired location relative to filter50, as illustrated in FIG. 11. Through viewing the insertion of capturecatheter 90 through a fluoroscope, a physician or clinician can placedistal end 94 to surround filter 50.

[0133] The lumen 92 of capture catheter 90 is adapted to receive filter50 and substantially completely enclose filter 50. The inside diameterof lumen 92 is configured to engage with struts 52 when they are in theopen configuration, i.e., filter 50 is in the deployed position, andpush struts 52 radially together to close opening 60. Through thisconfiguration, opening 60 is closed before distal end 94 of capturecatheter 90 contacts filter 50 and the engagement of capture catheter 90with filter 50 does not cause embolic material to escape from withinfilter 50.

[0134] As capture catheter 90 is advanced over filter 50, it iscompressed into lumen 92 of capture catheter 90. To limit the amount ofcompression of the embolic material within filter 50, a section of lumen92 which or that optionally has greater elasticity than the remainder ofcapture catheter 90, the border of this section being represented bydotted lines in FIG. 10. By so doing, this portion of capture catheter90 can expand around filter 50 and any captured embolic material.

[0135] Capture catheter 90 can have various configurations and befabricated from a variety of different materials. For example, capturecatheter 90 can be fabricated from metals, alloys, plastics, polymers,synthetic materials, composites, or other medical grade materials.Further, capture catheter 90 can be kink resistant, biocompatible,radiopaque, in whole or in part, and capable of being exchanged overguide member 12. Additionally, the elasticity of capture catheter 90 canbe constant along its length, variable along its length, constant alonga portion and variable along another portion of capture catheter 90, orcombinations thereof.

[0136] As illustrated in FIG. 10, disposed at proximal end 96 of capturecatheter 90 is a locking mechanism 98. The locking mechanism 98 engageswith the proximal end of guide member 12 to securely capture guidemember 12 when distal end 94 partially or completely surrounds filter 50(FIG. 11). In one configuration, locking mechanism 98 is an annularclamp that can be rotated to clamp a proximal end of guide member 12. Inanother configuration, locking mechanism 98 can be a rotating hemostatisvalve through which is disposed the proximal end of guide member 12. Instill another configuration, locking mechanism 98 can be a lockingjaw-set, such as a mechanical collett. Each of these locking mechanismscan be configured in a variety of different manners and fabricated froma variety of different materials as known to those skilled in the art.For instance, the locking mechanism can be fabricated from plastics,polymers, metals, synthetic materials, alloys, or various othermaterials.

[0137] According to another aspect of the present invention, filterdevice 10 is generally used with a fluoroscope that enables a physicianto view the insertion of filter device 10 through the tortuous anatomyof a patient. To enable filter device 10 to be visible to the physician,filter device 10 includes radiopaque bands, markers, or other means forradiopacity that provide reference points for the physician. Withreference to FIG. 7, various locations are illustrated as beingradiopaque by reference letter R. As shown, tip 15 of filter device 10is radiopaque. More specifically, the most distal portion of distal end14 is radiopaque so that the physician knows the location of tip 15 offilter device 10.

[0138] The distal end of actuating member 40 is radiopaque so that thephysician knows a (D, A, OA whether filter assembly 42 is in the stored,deployed, or retrieved position, while distal end 54 of filter 50includes a radiopaque marker that defines the most distal portion offilter device 10. Similarly, capture catheter 90 can include radiopaquebands, other markers, or means for radiopacity to define the distal endthereof.

[0139] In addition to the distal ends of guide member 12, capturecatheter 90, actuating member 40, and filter 50, embodiments of thepresent invention include radiopaque markers or other means forradiopacity at the junction of struts 52 and proximal end 58 of filter50. In this manner, a physician can view the location of opening 60during the procedure and verify that opening 60 is closed before thephysician retrieves filter device 10 when the procedure is completed.

[0140] Although reference is made to placing radiopaque bands or markersat various locations on the components of filter device 10, one skilledin the art can identify various other locations where radiopaque bands,markers, or other means for radiopacity are appropriate. Further,embodiments of the present invention need not include all discussedradiopaque bands or markers, but rather can include one or more of thedescribed radiopaque bands or markers as desired.

[0141] Following hereinafter is a discussion of an illustrative mannerby which a filter device of one embodiment of present invention isinserted into a carotid artery. Although reference is made to thepresent invention being inserted into a carotid artery, it can beunderstood by one skilled in the art that different methods can by usedto insert the filter device of the present invention into any bloodvessel within a patient.

[0142] With reference to FIGS. 12-17, initially, a small needle is usedto gain femoral access, as represented by block 110. This small hole issubsequently dilated until the hole is large enough to allow theinsertion of an introducer of appropriate size as known to one skilledin the art.

[0143] With reference to FIG. 13, it can be understood by one skilled inthe art, that a variety of different access sites can be used. Forexample, the right subclavian artery 210, left subclavian artery 206,right brachial artery 218, left brachial artery 215, right femoralartery 225, left femoral artery 220, right radial artery and left radialarteries 227, 228, or any other artery as known by one skilled in theart can be used to enter a patient's arterial circulation.Alternatively, as known by one skilled in the art, any other bloodvessel selectable by the physician can be chosen as an access site.

[0144] Referring now to FIGS. 12-17, following insertion of theintroducer, a guidewire 230 is inserted into the femoral access site andsteered, under fluoroscopy, to the desired location in the arterialsystem, just proximal to the lesion to be treated, as represented byblock 112. In this illustrative example, the following discussionrelates to stenting of a lesion in the internal carotid artery, asreferenced by arrow D in FIG. 12 and illustrated in FIG. 13.

[0145] Guidewire 230 and guide catheter 232 are advanced togetherincrementally until the distal tip of guidewire 230 is placed proximalto the lesion, as represented by block 114 and shown in FIG. 12. Uponplacing guide catheter 232, guidewire 230 is removed and filter device10 is advanced through guide catheter 232, as represented by block 116and illustrated in FIG. 14.

[0146] The filter device 10 is carefully advanced through the lesion toa point distal to the lesion and subsequently acts as an exchangeguidewire with a filter attached. Alternatively, filter device 10 canfunction as guide member 230 so that a physician need not exchangefilter device 10 for guidewire 230. In such a configuration, the stepsof placing the filter device and accessing the lesion can be performedsimultaneously. This particular configuration is useful because itlimited the number of exchanges performed by the physician andconsequently accelerates the performance of the procedure.

[0147] Once in position, moving actuating member 40 distally actuatesfilter device 10 and deploys filter 50, as represented by block 118 andshown in dotted lines in FIG. 15. In this manner, filter assembly 42 isdeployed from lumen 18 of guide member 12 and struts 52 expand to secureproximal end 58 of filter against the wall of the vessel, as shown inFIG. 6a. Alternatively, when struts 52 are formed from the same materialas filter 50, the flow of blood through the vessel causes proximal end58 to become secured against the wall of the vessel. Consequently, ineither case, the blood flowing through the lesion subsequently flowsthrough filter 50.

[0148] Next, a stent is placed over the lesion, as represented by block120. This may be preceded by advancing a pre-dilation balloon 234, suchas a relatively long, high-pressure balloon, over filter device 10,shown in dotted lines, until balloon 234 is within the lesion. Next,balloon 234 is inflated to dilate the lesion, as illustrated in FIG. 16,and then deflated and removed from the patient. Then a stent deliverysystem is advanced over guide member 12 until a stent 236, shown indotted lines in FIG. 17, is within the lesion. The stent delivery systemdeploys stent 236, which then expands to fit the interior of the lesionwithin the artery. Once stent 236 is thus deployed, the stent deliverysystem is then removed.

[0149] To secure stent 236 in place, a post-dilation balloon, having asimilar configuration to the pre-dilation balloon, is advanced overfilter device 10 until the balloon is within stent 236. Subsequently,the post-dilation balloon is inflated to a pressure and held at thedesired pressure for a period selected by the physician. The maintenanceof the balloon at such a pressure for this period causes stent 236 to beimbedded into the inner wall of the vessel. Following imbedding stent236 into the inner wall of the vessel, the balloon is deflated andremoved.

[0150] To complete the procedure, the devices within the patient andpunctured vessel and tissue are closed. With respect to filter device10, locking mechanism 20 is activated to cause actuating member 40 tomove in the proximal direction. The actuating member 40 draws struts 52within lumen 18 of guide member 12, thereby causing proximal end 58 offilter 50 to be retained within lumen 18, as illustrated in FIG. 8 andrepresented by block 122 in FIG. 12. In another configuration,activating actuating member 40 causes proximal end 58 of filter 50 tocontact distal end 26 of guide member 12, while remaining external fromlumen 18. In either case, the material captured within filter 50 areenclosed and prevented from escaping during removal of filter device 10.By locating proximal end 58 of filter 50 within lumen 18 or in contactdistal end 26 of guide member 12, filter device 10 securely encloses thematerial with a sufficiently low force to prevent escape of any materialbut not cause material to be extruded through the holes of filter 50.

[0151] Once filter 50 is in the retracted position, capture catheter 70is advanced over guide member 12 until the capture catheter enclosesfilter device 10, as illustrated in FIG. 11. This capture catheter isoptionally locked in place with respect to guide member 12 and thefilter system, including filter device 10. Subsequently, the capturecatheter 70 and the filter device 10 are removed from the patient, asrepresented by block 124. To complete the procedure, all remainingdevices are removed from the patient and the vessel puncture is closed.

[0152] The previously described embodiment of a filter device of thepresent invention is only one illustrative embodiment of the filterdevice. The following discussion provides various other configurationsof various alternate embodiments of the filter device, including theguide member, the capture catheter and various elements of components.The following embodiments can be used in a similar manner to filterdevice 10 in performing the above-discussed method to insert the filterdevice into a carotid artery or some other body lumen. Further, theapplicability of the features and functions discussed with respect tothe previously discussed embodiment of the present invention areapplicable to the to the following embodiments.

[0153] Referring now to FIG. 18 is another configuration or embodimentof the filter assembly and actuating assembly. As depicted in FIG. 18, afilter device 310 includes a guide member 312 having a distal end 314and a lumen 318 extending from distal end 314 toward a proximal end (notshown). In this particular configuration, a sheath and cover areexcluded from guide member 312. In another configuration, however, asheath and cover can be included in a similar manner to guide member 12.

[0154] Disposed within lumen 318 are a filter assembly 342 and anactuator 340, with associated head 344. The filter assembly 342 includesa filter 350, which can be similar to other filters described herein,and a plurality of struts 352 extending from filter 350 to actuator 340or head 344. Each strut 152 includes a distal portion 362, a proximalportion 366, and an intermediate portion 364 disposed between distalportion 362 and proximal portion 366. The struts 352 attach to filter350 on the exterior of filter 350, on the interior of filter 350, alongthe edge of filter 350, through filter 350, or combinations of one ormore of the proceeding. To provide additional surface area to connecteach strut 352 to filter 30, each strut 352 can be configured so thatdistal portion 362 has a cross-sectional dimension larger thanintermediate portion 364. Stated another way, distal portion 362 canhave a larger surface area than intermediate portion 364. The largecross-sectional area provided by the cross-sectional dimension of distalportion 312 provides large area for bonding each strut 352 to filter350. In this configuration, a strong bond is created between each strut352 and filter 350.

[0155] Similarly, each strut 352 can be configured so that proximalportion 366 has a cross-sectional dimension larger than intermediateportion 364, while optionally having a similar, larger, or smallercross-sectional dimension than distal portion 362. By having a largecross-sectional dimension and hence large surface area, each strut 352can be securely connected to actuating member 340 or head 342 which canbe similar to other actuating members and heads described herein.

[0156] By varying the cross-sectional dimensions of distal portion 362,intermediate portion 364, and/or proximal portion 366, the degree ofbias exerted by each strut 352 to move distal portion 362 toward thewall of a blood vessel can be varied. The biasing force can also bechanged through optionally varying the length of each strut 352 and/orchanging the curvature of each strut 352.

[0157] Although reference is made herein to each strut 352 having theabove-referenced configurations, one skilled in the art can appreciatethat one or more of struts 352 can be configured as described above.Further, each strut 352 can optionally be configured differently so thateach strut 352 can have similar or dissimilar biasing forces compared toothers struts 352 of the same filter device. Through varying the biasingforces, the my filter device can be used for a variety of differentprocedures or blood vessel configurations.

[0158] Struts 352 can be formed from Nitinol, stainless steel, metals,alloys, composites, plastics, polymers, synthetic materials, orcombinations thereof. Each strut 352 can have a generally curved distalportion 362, proximal portion 366, and/or intermediate portion 364.

[0159] Referring now to FIG. 19, illustrated is an alternate embodimentof actuator assembly, designated by reference number 420. Thisparticular embodiment of actuator 420 is capable of deploying andretrieving a filter assembly with use of a clamp assembly 472.

[0160] As illustrated, actuating assembly 420 includes an actuatingelement 470, and an actuating member 440, each of which can be similarto other actuating elements and actuating members described herein.Actuating element 470 includes a distal end 474 that is configured tocooperate with guide member 412, which can be similar to the other guidemembers described herein, while a proximal end 476 of actuating element470 is attached to proximal end of actuating member 440. The distal end474 has a step configuration and includes protrusions 478 that areconfigured to cooperate with complementary indentations 480 formed inguide member 412. As actuating element 470 is moved in the distaldirection, such as by a physician, clinician, or a device operated bythe physician, clinician, or technician, protrusions 478 andindentations 480 mate to position actuating element 470 in a desiredlocation relative to proximal end 416 of guide member 412, therebypositioning filter assembly 442 in a selected position, such as in theretracted position illustrated in FIG. 8.

[0161] As actuating element 470 is continually moved in the distaldirection, distal end meets a wall 482 formed in guide member 412 thatprevents further movement in the distal direction. Through thisconfiguration, actuating element 470 is prevented from excessivelongitudinal displacement in the distal direction. This stopping of thelongitudinal displacement of actuating element 470 indicates that filterassembly 442 is deployed.

[0162] As illustrated, actuator element 470 engages with clamp assembly472. The clamp assembly 472 includes two annular clamp sets 484 and 486.Clamp set 484 couples to actuator element 470, while clamp set 486couples to guide member 412. In this illustrative embodiment, clamp set484 is capable of being translated along the longitudinal axis of thefilter device, while clamp set 486 is fixed. Clamp set 484 can beconnected to a threaded screw, hydraulic rams, pneumatic rams, slidesystems, linear actuators, combinations thereof, or the like thatenables clamp set 484 to move in the proximal and distal directions. Forinstance, in one embodiment a threaded screw is rotatably attached toclamp set 486, with clamp set 484 mounted thereto. Upon rotating thethreaded screw, clamp set 484 advances along the threaded screw ineither the proximal or distal direction to open or retract the filterassembly (not shown) of the filter device.

[0163] Generally, clamp assembly 472 can include a variety of differentclamp sets, whether annular or opposed clamping jaws or clamp set, orthe like as known to one skilled in the art. Further, clamp assembly 472can use pneumatics, hydraulics, electricity, combinations thereof, orthe like to move actuator element 470 and/or guide member 412.

[0164] Referring now to FIG. 20, another illustrative embodiment of thepresent invention is depicted. As shown, a guide member 512, which canbe similar to the other guide member described herein, has a distal end514, a proximal end 516, and a lumen 518 extending from distal end 514to proximal end 516. A tip 515 of guide member 512 includes a pluralityof struts 522, such as three or more struts. Each strut 522 can bebiased such that a distal end thereof is biased to move outwardly fromthe longitudinal axis of guide member 512.

[0165] At least one strut, designated by reference numeral 524, isbiased toward the longitudinal axis of guide member 512, as shown inFIG. 21. Disposed upon strut portion 524, as more clearly seen in FIG.20, is a coil tip 526 that is commonly used with guidewires. This coiltip 526, either alone or in combination with strut 524, may beconfigured to allow a physician or clinician to shape the same beforeinsertion into a body lumen. In this manner, the physician or clinicianis able to configure the tip with an appropriately shaped J that enablesguide member 512 to be guided through the tortuous anatomy of a patient.The coil tip 526 can be platinum, platinum alloys, radiopaque materials,metals, alloys, plastic, polymer, synthetic material, combinationsthereof, or other materials that provide an appropriate radiopaquesignature, while capable of being shaped, whether alone or incombination with strut 524, by a physician or clinician.

[0166] Attached to the distal ends of two or more of struts 522 is afilter 550. As shown, filter 550 is disposed within lumen 518 of guidemember 512. In alternate embodiments, filter 550 can surround guidemember 512 or partially surround and partially be contained within lumen518. Filter 550 can have a variety of different configuration such asthose described with respect to the other filters described herein.

[0167] Filter 550 can be attached to guide member 512 via a variety ofdifferent techniques and methods as known to one skilled in the art. Forinstance, filter 550 can be attached through adhesives, solvent bonding,thermal bonding, mechanical connections, or some other manner that iscapable of securely connecting filter 550 to one or more of struts 522.In another configuration, a distal end of two or more struts 522 caninclude respective holes (not shown) through which strands of filter 550can be passed and attached to strut 522 to connect filter 550 to struts522. Alternately, the strands can be tied in a knot or folded back uponfilter 550 and woven into or affixed to filter 550.

[0168] To maintain struts 522 in the closed position, i.e., notextending outwardly from guide member 512, a catheter 540 surroundsguide member 512. The catheter can extend completely or partially fromthe distal end to the proximal end of guide member 512. Illustratively,the catheter can surround substantially only struts 522. The catheter540 acts as a restraining member or mechanism that applies a forceagainst, the struts to prevent the struts from extending outwardly.Catheter 540 can have a lumen (not shown) that has an inside diameterthat is sufficiently similar to the outside diameter of guide member 512that struts 522 are restrained from extending outwardly. Through movingguide member 512 with respect to catheter 540, or vice versa, the distalends of two or more of struts 522 are allowed to move outwardly todeploy filter 550, as illustrated in FIG. 21 that depicts guide member512 having two struts 522. Retracting filter 550 and catheter 540 can beperformed in a similar manner to that described with respect to theother filter devices discussed herein, such as but not limited to usinga capture catheter.

[0169] As mentioned above, the catheter can extend completely orpartially the length of the guide member. In another configuration, thecatheter can be replaced with a sleeve, a band, or other structure thatpartially extends toward the proximal end of the guide member from thedistal end. These sleeves, bands, or other structures can be radiopaqueor include one or more radiopaque markers. Furthermore, these sleeves,bands, or other structures can be slidable relative to the guide memberusing an actuating member that is disposed on the exterior of the guidemember, within the lumen of the guide member, or partially within thelumen and partially on the exterior of the guide member. The actuatormember can be any of the actuator members described herein.

[0170] According to an alternate configuration of the present invention,a filter device 610 includes a guide member 612 with a plurality ofstruts 622 disposed at a distal end 614 thereof. These struts 622 can bemaintained in the closed position using a sleeve 660, as illustrated inFIG. 22. The sleeve 660 acts as a restraining member or mechanism thatapplies a force against the struts to prevent the struts from extendingoutwardly.

[0171] Sleeve 660 surrounds struts 622, and a filter 650, which can besimilar to other filters described herein, when filter 650 is located onan exterior surface of guide member 612. Disposed within sleeve 660 orbetween sleeve 660 and guide member 612 and/or filter 650 are one ormore actuating members or actuating members 654. These actuating members654 are attached to guide member 612 at a location just proximal to theproximal end of each struts 622, identified by letter E, extend distallyto the distal end of sleeve 660, and subsequently extend proximally onthe outside of sleeve 660 to terminate at an actuating element 670 of anactuating assembly 620 (FIG. 25) via one or more holes 656 and lumen618. Since one end of each actuating member 654 is located at theproximal end of sleeve 660, whether forming part of sleeve 660, attachedto sleeve 660, attached to guide member 612, or combinations it,thereof, pulling actuating member 654 in the proximal direction byactuating element 670 of actuating assembly 620 (FIG. 25) causesactuating member 654 to preferentially separate sleeve 660 into one ormore portions, thereby releasing struts 622, as illustrated in FIG. 24.

[0172] Stated another way, and with reference to FIG. 25, one or more ofactuating members 654 can cooperate with an actuating assembly 620 andconnect to actuating element 670, such as through soldering, adhesives,or other forms of attachment. The actuating element 670 can be moved inthe proximal direction until a stop member 672 formed in a proximal end616 of actuating element 670 engages with a stop member 674 in guidemember 612. During the movement from a distal end 676 of actuatingelement 670 cooperating with a surface 678 of guide member 612 to stopmember 672 engaging with stop member 674, actuating member 654 moves ina proximal direction to preferentially separate sleeve 660.

[0173] Sleeve 660 can be formed from a variety of different materials,so long as the material is sufficiently strong to secure struts 522,while being configured to preferentially separate under the action ofactuating member or actuating member 654. For example, sleeve 660 can befabricated from heat shrink synthetic material, including but notlimited to, low-density polyethylene (LDPE), polyethylene terphthalate(PET), Polytetrafluoroethylene (PTFE), fluorinated ethylene propylene(FEP), polyethylene (PE), polyurethane (PU) or silicone tubing.

[0174] Actuating members 654 can be formed from a variety of differentmaterials, so long as the material used is sufficiently strong to allowan actuating mechanism, such as those actuating mechanisms disclosedherein, to move actuating members or actuating member 654 proximallywithout breaking the same. For example, actuating members 654 can befabricated from plastics, polymers, metals, composites, alloys,synthetic materials, or combinations thereof.

[0175] Instead of using actuating members 654, embodiments of thepresent invention can employ various other manners to preferentiallyseparate sleeve 660. For example, sleeve 660 can have dissolvablechemical bonds which dissolve due to a chemical reaction with the fluidin the vessel within which the filter device is disposed, bonds that arebroken through applying resistive heating, ultrasonic or radio frequencyenergy, preferential regions or zones where the material has a weakerstrength than other regions or zones of the sleeve, or combinationsthereof.

[0176] Following is a discussion of other methods, devices, and systemsfor restraining or constraining one or more struts attached to orintegrally formed as part of a guide member. The embodiments providemethods, devices, and systems for, applying a restraining force to oneor more struts and subsequently releasing the same to allow the strutsto expand outwardly.

[0177] Referring now to FIG. 26, depicted is a perspective view of oneembodiment of a restraining member or mechanism. The restraining memberor mechanism, is in the form of a sleeve 760 and associated securingmember 762, the combination of which is adapted to surround one or morestruts 752 of a guide member 712 and apply a restraining force againststruts 752 to maintain struts 752 in a closed configuration. The sleeve760 includes a first side 764 and a second side 766 with first andsecond sides 764, 766 being separated by an intermediate portion 768.The sleeve 760 surrounds guide member 712 in such a manner thatintermediate portion 768 surrounds guide member 712 so that portions ofintermediate portion 768 contacts with, are juxtaposed to, arecontiguous with, or are adjacent one to another. The securing member 762passes through such portions of intermediate portion 768 to securesleeve 760 upon guide member 712. To further aid with applying arestraining force against struts 752, first side 764 and second side 766are folded to attach to respective portions of outside surface of sleeve760.

[0178] The process of forming the restraining member or mechanism ofFIG. 26 is illustrated in FIGS. 27 and 28. With reference first to FIG.27, which depicts sleeve 760 in an open position before securing member762 is coupled thereto, sleeve 760 can be directly formed on guidemember 712 or can be formed on a separate tubular member andsubsequently attached or coupled to guide member 712. Sleeve 760 isillustrated as having a generally polygonal configuration, however, oneskilled in the art can appreciate that sleeve 760 can have various otherconfiguration so long as it is capable of performing the functionsdescribed herein. In this exemplary configuration, sleeve 760 is coupleddirectly to a guide member 712. The first side 764 and second side 766of sleeve 760 are wrapped around at least a portion of guide member 760,until a portion of intermediate portion 768 is in close proximityanother portion of intermediate portion 768. Alternatively, a first side764 can be contacting, juxtaposed, contiguous, or adjacent to secondside 766.

[0179] When the portions of intermediate portion 768 are in closeproximity, securing member 762, or alternatively some other actuatingmember, is stitched through both sleeve 760 to couple the portions ofintermediate portion 768, as shown in FIG. 28. Once securing member 762is drawn straight, first end 764 and second end 766 are folded to attachto respective outside surfaces of sleeve 760, as shown in FIG. 25.

[0180] In an alternate configuration, as illustrated in FIG. 29, sleeve760 can include a plurality of apertures 780 on portions of intermediateportion 768 that receive securing member 762 thereby allowing securingmember 762 to be passed through apertures 780 rather than stitchedthrough sleeve 760. In another embodiment, first end 764 of sleeve 760can be coupled to second end 764 of sleeve 760 without attaching firstend 764 or second end 766 to the outside surface of sleeve 760.Depending upon the particular configuration, a portion of first end 764can overlap a portion of second end 766, or vice versa. Alternatively,first end 764 and second end 766 contact each other but do not overlap.Similarly, first end 764 and second end 766 can be adjacent to oneanother, adjoining one another, contiguous to one another, or juxtaposedto one another.

[0181] To operate the restraining member or mechanism described inreference to FIGS. 26-29, a proximal end (not shown) of securing member762 extends to a proximal end (not shown) of guide member 712, eitherwithin or without a lumen of the guide member 712. Disposed upon the endof securing member 762 is an actuating member, such as actuating member20, which allows a physician or clinician to move securing member 762longitudinally to remove securing member 762 from being disposed throughat least a portion of sleeve 760. By so doing, the restraining forceapplied by sleeve 760 is released, struts 752 extend outwardly, and thefilter (not shown) is deployed.

[0182] Sleeve 760 can be formed from a variety of different materials,so long as the material is sufficiently strong to restrain one or morestruts 752. For example, sleeve 760 can be fabricated from various typesof polymer or silicone films, such as but not limited to, heat shrinkplastic, polymer, low-density polyethylene (LDPE), polyethyleneterphthalate (PET), Polytetrafluoroethylene (PTFE), fluorinated ethylenepropylene (FEP), polyethylene (PE), polyurethane (PU), or siliconetubing.

[0183] Securing member 762 can be formed from a variety of differentmaterials, so long as the material used is sufficiently strong to allowthe actuating mechanisms disclosed herein to move securing member 762proximally without breaking securing member 762. For example, securingmember 762 can be fabricated from plastics, polymers, metals,composites, alloys, synthetic materials, combinations thereof, or othermaterial that is capable of performing the function of being disposedthrough sleeve 760 and capable of being withdrawn therefrom.

[0184] Referring now to FIGS. 30-34, illustrated is another alternateconfiguration of a restraining member or mechanism. This particularconfiguration utilizes a hinged configuration with a securing memberacting as the pin to maintain the hinged portions of a sleeve in aclosed configuration to constrain or restrain a portion of the guidemember.

[0185] As shown in FIG. 30, a sleeve 860 includes a plurality ofchannels 864 a-864 f that are adapted to receive a securing member 862.Both a first side 866 and a second side 868 of sleeve 860 are formedwith some of channels 864 a-864 f, i.e., channels 864 a, 864 c, and 864e on first side 866 and channels 864 b, 864 d, and 864 f on second side868. Through passing securing member 862 through channels 864 a-864 f insequential order, so that securing member 862 passes through a channelon first side 866 and subsequently a channel on second side 868, firstside 866 is coupled to second side 868 and sleeve 860 applies arestraining force against the struts (not shown) of a guide member.

[0186] The process of forming the restraining member or mechanism ofFIG. 30 is illustrated in FIGS. 31-34. With reference first to FIG. 31,which depicts sleeve 860 in an open position before securing member 862is coupled thereto, sleeve 860 includes a number of extensions ortongues 870 a-870 n. These extensions 870 a-870 n are configured tosurround a tubular member or tube, such as but not limited to, a guidemember 812, and form channels 864 a-864 f within which securing member862 is located, as will be described hereinafter.

[0187] To attach sleeve 860 to guide member 812, sleeve 860 ispositioned over the desired portion of guide member 860. The securingmember 862 is placed in close proximity to guide member 860, as shown inFIGS. 31 and 32. The ends of the extensions 870 a-870 n are insertedbetween guide member 860 and securing member 862, as shown in FIG. 33.Alternatively, extensions 870 a-870 n can be partially wrapped aroundguide member 812 and securing member 862 placed into contact with thesepartially wrapped extensions 870 a-870 n.

[0188] After the extensions 870 a-870 n are pulled tightly around guidemember 812 and securing member 862, an end of each extension 870 a-870 nis folded over securing member 862 to attach to the outer surface ofsleeve 860, as shown in FIGS. 30 and 34. In this manner, channels 862a-862 n are formed and sleeve 860 is configured with securing member 862to releasably restrain the struts (not shown) of guide member 812.

[0189] Releasing the restraining force applied by sleeve 860, alone orin combination with securing member 862, is achieved through moving orpulling securing member 862 longitudinally with respect to guide member812. The securing member 862 is withdrawn from channels 864 a-864 f toallow the biasing force of the struts (not shown) to extend the strutsoutwardly to deploy the filter (not shown). The longitudinal motion ofsecuring member 862 can be initiated through a variety of differentmechanisms as described herein, such as but not limited to actuatingassembly 20, or otherwise known to one skilled in the art in light ofthe teaching contained herein.

[0190] Referring now to FIG. 35, depicted is another embodiment of arestraining member or mechanism of the present invention. Therestraining member 960 includes a number of hoops 964 a-96 n that areadapted to receive a securing member 962. In a similar manner to thatdescribed with respect to other embodiments of the restraining member ormechanism, securing member 962 is disposed within hoops 964 a-964 n sothat restraining member 960 applies a retaining force against the strutsof a guide member 912. The securing member 962 can be removed from hoops964 a-964 n to thereby allow the struts to extend outwardly to deploythe filter (not shown). The restraining member 960 may be made frommetallic wires, polymer fibers, or other materials that can bemanipulated to form hoops through which a securing member is disposedand which can expand outwardly either under the influence of one or morestruts or due to a biasing force applied by the configuration and/ormaterial of the restraining member.

[0191] The restraining member 960 can be attached to guide member 912and/or one or more of the struts associated therewith through variousattachment mechanisms. For instance, restraining member 960 can beattached to guide member and/or one or more of the struts throughadhesives, mechanical fasteners, securing loops, or other manner thatsecurely attaches restraining member 960 to the guide member and/or oneor more of the struts. Alternatively, restraining member 960 may beattached to securing member 962 and be removed when securing member 962is moved in a proximal direction.

[0192] Referring now to FIGS. 36-39, depicted is another embodiment of arestraining member or mechanism of the present invention. Instead of aseparate restraining member or mechanism that is connected to a guidemember, the filter media itself is adapted to function both as a filterand as a restraining member or mechanism.

[0193] As illustrated, a guide member 1010 includes a plurality ofstruts 1052 that are adapted to extend outwardly to deploy a filter 1050that is disposed within a lumen 1018 of guide member 1010. The filter1050 includes two flaps 1060 and 1062 that extend between a gap 1064between two struts 1052. These flaps 1060 and 1062 are adapted to bepulled around struts 1052 to compress them and secure filter 1050 withinlumen 1018, as illustrated in FIG. 37. These flaps 1060 and 1062 can beintegral with filter 1050, two separate members that are bonded orotherwise connected to filter 1050, or a single member that has anintermediate portion bonded or otherwise connected to filter 1050, withthe ends of the member forming flaps 1060 and 1062.

[0194] When flaps 1060 and 1062 have been positioned to securely retainstruts 1052, they are then stitched together at a location 1066identified in FIG. 38 with an actuating member 1070. This actuatingmember 1070 extends the length of the filter device to cooperate with anactuating assembly, such as but not limited to an actuating assemblydescribed herein and those others known to one skilled in the art inlight of the teaching contained herein.

[0195] Following the coupling of flaps 1060 and 1062 using actuatingmember 1070, flaps 1060 and 1062 are folded back around the bundledstruts 1052 and filter 1050, and then attached to filter 1050, struts1052, or other portion of guide member 1012, as illustrated in FIG. 39.When actuating member 1070 is moved in a proximal direction, flaps 1060and 1062 are released and filter 1050 is deployed as struts 1052 extendoutwardly.

[0196] Although reference is made to two flaps 1060 and 1062, oneskilled in the art can appreciate that the filter can includes one ormore flaps. For instance, one flap can be wrapped around struts 1052 andan end of the flap sewn or otherwise releasable connected to filter1050.

[0197] Referring now to FIG. 40, depicted is another embodiment of arestraining member or mechanism of the present invention. Thisparticular configuration is depicted as part of a filter assembly 1142that can be coupled to or attached to a distal end of a guide member.The filter assembly 1142 can includes a strut assembly 1144 and a filter(not shown) coupled to strut assembly 1144. The strut assembly 1144 hasan elongated proximal end 1146 and a distal end 1148 having a pluralityof struts 1152. The length of elongated proximal end 1146 can vary basedupon the particular configuration of the guide member. For instance,proximal end 1146 can have any length greater than 1 centimeter.

[0198] As mentioned above, disposed at distal end 1148 are struts 1152.Each strut 1152 includes a tubular member 1154 adapted to receive asecuring member 1162. Adjacent tubular members 1154 on adjacent struts1152 are staggered such that when struts 1152 are brought togethersecuring member 1162 can be disposed through tubular members 1154 torestrain struts 1152 and prevent them from extending outwardly, asillustrated in FIG. 41.

[0199] The securing member 1162 can extend through a lumen 1164 of strutassembly 1144 into a lumen 1118 of guide member 1112 to terminate at anactuating assembly (not shown) at a proximal end 1116 of guide member1112. Alternatively, securing member 1162 can extend through lumen 1164to exit through an aperture 1166, depicted in dotted lines, in strutassembly 1144 before terminating at an actuating assembly (not shown) ata proximal end of guide member 1112. In still another configuration,securing member 1162 can pass into lumen 1164 through aperture 1166,depicted in dotted lines, in strut assembly 1144 before terminating atan actuating assembly (not shown) at a proximal end of guide member1112.

[0200] Each tubular member 1154 coupled to struts 1152 can be fabricatedfrom a metal, a plastic, polymer, a polymer, a synthetic materials,whether or not the material is the same as that forming guide member1112. In one embodiment, each tubular member 1154 is a polymer tube,such as a polyimide or polyurethane tube that is fixed to respectivestruts 1152 with adhesive. In another configuration, each tubular member1154 is a metallic cut tube that may be attached to respective struts1152 with and adhesive or solder. In still another configuration, eachstrut 1152 includes an aperture through which securing member 1162passes to restrain struts 1152 and prevents the same from extendingoutwardly.

[0201] Referring now to FIG. 42 is another configuration or embodimentof a device according to another aspect of the present invention. Asdepicted in FIG. 42, a filter device 1210 includes a guide member 1212having a distal end 1214 and a lumen 1218 extending from distal end 1214toward a proximal end (not shown). In this particular configuration, andfor ease of explanation, filter device 1210 is devoid of a restrainingmember or mechanism, however, in other configurations, filter device1210 can include a restraining member or mechanism.

[0202] Disposed at distal end 1214 are a plurality of struts 1252,coupled to which is a filter 1250. Although reference is made herein tostruts 1252 being integrally formed with guide member 1212, it can beappreciated that struts 1252 can be part of a strut assembly that isattached to proximal end 1214 of guide member 1212. For instance, thestruts assembly can have a proximal end that terminates substantiallywith a proximal end of the guide member or at a location distal to theproximal end of the guide member, whether such location is close to thedistal end of the guide member or the proximal end of the guide member.

[0203] Each strut 1252 includes a distal portion 1262, a proximalportion 1266, and an intermediate portion 1264 disposed between distalportion 1262 and proximal portion 1266. The struts 1252 attach to filter1250 on the exterior of filter 1250, on the interior of filter 1250,along the edge of filter 1250, through filter 1250, or combinations ofone or more of the proceeding. To provide additional surface area toconnect each strut 1252 to filter 1250, each strut 1252 can beconfigured so that distal portion 1262 has a cross-sectional dimensionlarger than intermediate portion 1264. Stated another way, distalportion 1262 can have a larger surface area than intermediate portion1264. The large cross-sectional area provided by the cross-sectionaldimension of distal portion 1212 provides large area for bonding eachstrut 1252 to filter 1250. In this configuration, a strong bond iscreated between each strut 1252 and filter 1250.

[0204] Similarly, each strut 1252 can be configured so that proximalportion 1266 has a cross-sectional dimension larger than intermediateportion 1264, while optionally having a similar, larger, or smallercross-sectional dimension than distal portion 1262. By having a largecross-sectional dimension and hence large surface area, each strut 1252can apply a greater biasing force to extend strut 1252 outwardly todeploy filter 1250.

[0205] By varying the cross-sectional dimensions of distal portion 1262,intermediate portion 1264, and/or proximal portion 1266, the degree ofbias exerted by each strut to move distal portion 1262 toward the wallof a blood vessel can be varied. The biasing force can also be changedthrough optionally varying the length of each strut 1252 and/or changingthe curvature of each strut 1252.

[0206] Although reference is made herein to each strut 1252 having theabove-referenced configurations, one skilled in the art can appreciatethat one or more of struts 1252 can be configured as described above.Further, each strut 1252 can optionally be configured differently sothat each strut 1252 can have similar or dissimilar biasing forcescompared to others struts 1252 of the same filter device. Throughvarying the biasing forces, the filter device can be used for a varietyof different procedures or blood vessel configurations.

[0207] Struts 1252 can be formed from Nitinol, stainless steel, metals,alloys, composites, plastics, polymers, synthetic materials, orcombinations thereof. Each strut 1252 can have a generally curved distalportion 1262, proximal portion 1266, and/or intermediate portion 1264.

[0208] Disposed with lumen 1218 at distal end 1214 is a core 1260forming part of an atraumatic tip 1262. Surrounding at least a portionof core 1260 is a coil 1264 that provides flexibility and radiopaqueproperties to atraumatic tip 1262. The core 1260 passes through anaperture 1266 in a distal end of filter 1250. Alternatively, core 1260passes through one or more pores formed in filter 1250.

[0209] To secure filter 1250 to atraumatic tip 1262, a securing coil1270 surrounds a portion of coil 1264 and the distal end of filter 1250.Although this is one manner to connect filter 1250 to atraumatic tip1262, one skilled in the art can identify various other manners toconnect filter 1250 to atraumatic tip 1262. For instance, the distal endof filter 1250 can be bonded to atraumatic tip 1262 using adhesives,mechanical fasteners, crimping, seals, friction fit, press fit, or othermanners to connect filter 1250 to atraumatic tip 1262. In anotherconfiguration, filter 1250 is not connected to atraumatic tip 1262 butcan slide along a portion of atraumatic tip 1262.

[0210] Referring now to FIG. 43, another illustrative embodiment of thepresent invention is depicted. The majority of the features previouslydiscussed with respect to other embodiments of the present inventionapply to this exemplary embodiment.

[0211] A filter assembly 1342 comprises a filter 1350 and a springmember 1364. Filter 1350 includes a plurality of struts 1352. Thesestruts 1352 are lengthened strands of filter 1350. These struts 1352connect filter 1350 to actuating member 1340 and are unbiased.Alternatively, struts 1352 can be biased to open filter 1350.

[0212] Disposed at proximal end 1358 of filter 1350, is biased springmember 1364. Biased spring member 1364 has a coil-type configuration andincludes a proximal end 1368 that extends into lumen 1318 of guidemember 1312 to be attached to actuating member 1340, such as similar toactuating member 40 discussed herein, and/or a head 1344. Spring member1364 is biased to an opened position where spring member 1364 formsopening 1360. During deployment of filter assembly 1342, the flow ofblood through the blood vessel applies a force to filter 1350. Thisforce enables filter 1350 to be withdrawn from lumen 1318 and becomedeployed into the form described herein. Since spring member 1364 isbiased to open, spring member 1364 draws the outer peripheral edge offilter 1350 at proximal end 1358 toward the inner wall of the bloodvessel.

[0213] To retract filter 1350, actuating member 1340 is moved in theproximal direction, causing proximal end 1358 of filter 1350 to be drawnproximally. This causes proximal end 1358 to be drawn toward lumen 1318and become closed, thereby enabling filter 1350 to be removed throughthe procedure discussed herein, such as through use of a capturecatheter.

[0214] Various configurations of capture catheter are known to thoseskilled in the art in light of the teaching contained herein. Thecapture catheters described herein can be used with any of theembodiments of the filter device or guide member described herein.

[0215] As illustrated in FIG. 44 an alternate embodiment of a capturecatheter, designated by reference number 1390 is illustrated. As shown,capture catheter 1390 includes a distal portion 1392 and a positioningmember 1394 connected or attached to distal portion 1392. The distalportion 1392 includes a lumen 1400 extending from a distal end 1396 toterminate at an aperture 1402 at a proximal end 1398 thereof. The distalend 1396 optionally includes a radiopaque marker or band 1408, whilelumen 1400 is configured to receive a filter assembly of a filter devicein a similar manner to lumen 92 of capture catheter 90. Alternatively,lumen 1400 can include a stop member 1404, depicted in dotted lines,with a hole 1406 therethrough. The stop member 1404 allows guide member1412 to pass through hole 1406, but prevents a filter assembly disposedat a distal end of guide member 1412 to pass through hole 1406 oncecapture catheter 1390 has received the filter assembly within lumen1400. One skilled in the art can identify various other configurationsof stop member. For instance, hole 1406 can be disposed in stop member1404 at any location.

[0216] To move capture catheter 1390 along guide member 1412 of thefilter device, capture catheter 1390 includes positioning member 1394.This positioning member 1394 has sufficient stiffness that applicationof a force at a proximal end 1416 can be transferred to longitudinalmotion of distal portion 1392 of capture catheter 1390. In oneconfiguration, positioning member 1394 is a solid member, while inanother configuration positioning member 1394 is hollow or has at leasta portion thereof hollow. The positioning member 1394 can be fabricatedfrom a polymer, a plastic, polymer, a synthetic material, a metal, analloy, combinations thereof, or other material that can be used formedical devices and has the needed stiffness.

[0217] As illustrated in FIG. 45 an alternate embodiment of a capturecatheter, designated by reference number 1420 is illustrated. As shown,capture catheter 1420 includes a distal end 1422 and a lumen 1424extending from distal end 1422 to terminate at an aperture 1426 at alocation proximal to distal end 1422. Lumen 1424 is configured toreceive a filter assembly of a filter device in a similar manner tolumen 92 of capture catheter 90, while aperture 1426 is adapted toreceive guide member 1412 and prevent passage of filter assembly of thefilter device. In this configuration, the length of lumen 1424 isconfigured to prevent capture catheter 1420 from being advanced furtherover the filter device or filter assembly of the filter device than isrequired. Alternatively, lumen 1424 can include a stop member similar tostop member 1404 discussed herein. Furthermore, capture catheter 1420can optionally include one or more radiopaque markers disposed at and/orbetween a distal end and a proximal end thereof.

[0218] Referring now to FIG. 46, depicted is another embodiment of acapture catheter in accordance with another aspect of the presentinvention. As illustrated, capture catheter 1490 is adapted to cooperatewith a filter device 1510. The illustrative filter device 1510 includesa filter assembly 1542 coupled to a distal end 1514 of guide member1512. The filter assembly 1542 includes a plurality of struts 1552 and afilter 1550 connected to one or more of the plurality of struts 1552. Asshown, filter assembly 1542 is a separate component that is attached,connected, or coupled to guide member 1512. In an alternateconfiguration, however, filter assembly 1542 can be integrally formedwith guide member 1512, such that each of the plurality of struts 1552is formed from a portion of guide member 1512. Also forming part offilter assembly 1542 is an atraumatic tip 1560. This atraumatic tip 1560can be disposed through filter 1550 of filter assembly 1542.Alternatively, atraumatic tip 1560 can pass around filter 1550, asdepicted in dotted lines, and be configured from one of the plurality ofstruts 1552 that elongated.

[0219] Returning to capture catheter 1490, the capture catheter 1490includes a distal portion 1492 and a proximal portion 1494 thatcommunicates with the distal portion 1492. The proximal portion 1494 isstiffer than the distal portion 1492 and can have a similarconfiguration to the other capture catheters described herein. Forinstance, proximal portion 1494 can be capture catheter 90, can have asimilar configuration to distal portion 1392 of capture catheter 1390,or can be capture catheter 1420. The distal portion 1492 is flexible andtapers from proximal to proximal portion 1494 to a distal end 1498 ofcapture catheter 1490.

[0220] Disposed at distal end 1498 is a lumen 1500 that receives guidemember 1512 of filter device 1510. Lumen 1500 can be formed from aseparate tubular member that is connected, attached, or coupled to thedistal end of capture catheter 1490. Alternatively, lumen 1500 can beformed from the distal portion 1492 of capture catheter 1490. The lumen1500 is adapted to slidably receive guide member 1512 of filter device1510, but prevent passage of filter assembly 1542. Stated another way,filter assembly 1542 has an outer diameter greater than the innerdiameter of lumen 1500. Consequently, as capture catheter 1490 is movedin a distal direction, distal end 1498 engages with either a proximalend of filter assembly 1542 or one or more of the extending struts 1552.As capture catheter 1490 continues to be advanced, distal portion 1492,due to its flexibility, begins to invert, as depicted in FIG. 47. Ascapture catheter 1490 is continued to be advanced, struts 1552 andfilter 1550 are completely enclosed within capture catheter 1490, asshown in FIG. 48.

[0221] Embodiments of the present invention and the various componentsor elements thereof can be used interchangeably so that features andfunctions of one exemplary embodiment of a filter device can be usedwith other embodiments of the filter device. Illustratively, therestraining members or mechanisms of the described embodiments of thepresent invention can be used with multiple different configurations ofthe filter device. Further, exemplary capture catheters can be usedinterchangeably such that any capture catheter can be used with any ofthe described filter devices and such other that may be known to thoseskilled in the art in light of the teaching contained herein.Additionally, methods of using one embodiment of the present inventioncan be used with other embodiments of the present invention. Therefore,embodiments of the present invention provide filter devices that havesmall, low, or no profiles, few parts and components, are simple tomanufacture and use, are able to be easily inserted into a patient, besteerable through the tortuous anatomy of a patient, provide filteringcapabilities, provide exchange capability so other medical devices canbe advanced over or along the filter device, and be capable of removingcaptured material without allowing such material to escape during filterretrieval.

[0222] The present invention may be embodied in other specific formswithout departing from its spirit or essential characteristics. Thedescribed embodiments are to be considered in all respects only asillustrative and not restrictive. The scope of the invention is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A filter device for percutaneous insertion into ablood vessel during a procedure, the filter device comprising: (a) aguide member comprising a distal end, a proximal end, and a lumenextending from the distal end to the proximal end, said guide memberbeing configured to act as an exchange guidewire; (b) means forfiltering material from a blood stream, said means being disposed withinsaid lumen of said guide member; and (c) means for deploying said meansfor filtering from said lumen of said guide member into the blood streamin the blood vessel and retracting said means for filtering uponcompleting the procedure.
 2. A filter device as recited in claim 1,wherein said means for deploying comprises an actuating assembly.
 3. Afilter device as recited in claim 2, wherein said actuating assemblycomprises an actuating member and an actuating element.
 4. A filterdevice as recited in claim 3, wherein said actuating element is moveableby a human.
 5. A filter device as recited in claim 3, wherein saidactuating element is a moveable by a removable clamp set.
 6. A filterdevice as recited in claim 3, wherein said actuating element is coupledto said guide member.
 7. A filter device as recited in claim 3, whereinsaid actuating element comprises an open indicator, a closed indicator,and a retracted indicator.
 8. A filter device as recited in claim 1,wherein said means for filtering comprises a filter.
 9. A filter deviceas recited in claim 1, wherein said means for deploying comprises anactuating member coupled to an actuator head, said actuator headcommunicating with said means for filtering.
 10. A filter device asrecited in claim 1, wherein said means for filtering comprises means foropening an end of said means for filtering.
 11. A filter device asrecited in claim 10, wherein said means for opening comprises a biasedmember.
 12. A filter device comprising: (a) a guide member comprising adistal end, a proximal end, and a lumen extending from said distal endto said proximal end; (b) an actuating assembly coupled to said guidemember, said actuating assembly comprising: (i) an actuating memberdisposed within said lumen of said guide member; and (ii) an actuatingmechanism coupled to said distal end of said guide member and to saidactuating member; and (c) a filter assembly disposed within said lumenand configured to be deployed by said actuating member, said filterassembly comprising: (i) a filter comprising a proximal end with anopening formed therein; and (ii) a plurality of struts coupled to saidproximal end of said filter and said actuating member, at least one ofsaid plurality of struts being biased to open said opening.
 13. Thefilter device a recited in claim 12, wherein said actuating member isdisposed in said lumen of said guide member.
 14. The filter device arecited in claim 12, wherein said actuating member is partially disposedin said lumen of said guide member.
 15. A filter device as recited inclaim 12, wherein said filter assembly comprises means for opening saidopening formed in the filter.
 16. A filter device as recited in claim15, wherein said means for opening comprises a biased member.
 17. Afilter device as recited in claim 16, wherein said biased member is aflexible member.
 18. A filter device as recited in claim 16, whereinsaid biased member is a spring member.
 19. A filter device as recited inclaim 15, wherein said means for opening comprises said actuatingmember.
 20. A method for operating a vascular filter device during aprocedure, comprising: (a) inserting a filter device into thevasculature of a patient distal of a portion of a blood vessel to beaccessed during a procedure, said filter device comprising: (i) a guidemember having a proximal end, a distal end, and a lumen extending fromsaid distal end; and (ii) a filter disposed within said lumen at saiddistal end of said guide member; (b) deploying said filter from withinsaid lumen into the blood stream to capture material that is dislodgedduring the procedure; (c) retracting said filter until an open-endedproximal end thereof is positioned in relationship with said guidemember to prevent said captured material from escaping from said filter;and (d) upon positioning a capture catheter to enclose said filter,removing said filter device and said capture catheter from thevasculature of the patient.
 21. A method as recited in claim 20, furthercomprising locking said capture catheter to said guide member.
 22. Amethod as recited in claim 20, where said filter device comprises meansfor an actuating member coupled to said guide member.
 23. A method asrecited in claim 22, further comprising actuating said actuating memberto deploy said filter.
 24. A method as recited in claim 20, whereinretracting said filter comprises retracting said open-ended proximal endof said filter until said proximal end is in contact with said guidemember.
 25. A method as recited in claim 20, wherein retracting saidfilter comprises retracting said open-ended proximal end of said filterinto said lumen of said guide member.
 26. A method as recited in claim20, wherein deploying said filter comprises pushing said filter fromsaid lumen.
 27. A method as recited in claim 26, further comprisingexpanding said proximal end of said filter to form said opening.
 28. Amethod as recited in claim 27, wherein expanding said proximal endfurther comprises automatically expanding said proximal end throughrotational motion of an actuating member disposed in said lumen.
 29. Amethod for removing a vascular filter device, comprising: (a) followingdeploying a filter of a filter assembly from a guide member by moving anactuating member disposed within a lumen of said guide member in adistal direction, retracting said filter until an opened proximal end ofsaid filter is positioned in relationship with said guide member toprevent the captured material from escaping from said filter; and (b)upon positioning a capture catheter to enclose said filter, removingsaid filter device and said capture catheter from the vasculature of thepatient.
 30. A method as recited in claim 29, wherein retracting saidfilter comprises moving said actuating member in a proximal direction bymoving an actuator element in a proximal direction.
 31. A method asrecited in claim 30, wherein moving said actuating member furthercomprises moving a first clamp set coupled to said actuator element tomove said actuating member.
 32. A method as recited in claim 30, whereinmoving said actuating member further comprises moving said actuatorelement by-hand to move said actuating member.
 33. A method as recitedin claim 30, further comprising locking said capture catheter to saidguide member.